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Caregiver BurdenCONFIDENCENCT05292248

CONFIDENCE Financial Education for Caregivers

A study testing Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving in people with Caregiver Burden and Financial Stress, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine how feasible it is to deliver an online course to reduce out-of-pocket costs of caregiving and reduce financial stress among Latino family caregivers to a family member living with dementia. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Caregiver Burden, Financial Stress, Dementia
What is being tested?
Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 May 2022to 1 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Caregiver to someone diagnosed by a physician with probably Alzheimer's disease or a related dementia at least 6 months ago
  • Latino or Hispanic ethnicity
  • At least 50 years of age of older
  • Able to attend 5, 1.5 hour to 2 hour group-based lessons over 5 weeks
  • No plans to place family member in a facility within the next 3 months

Who cannot join

  • Unreliable access to email, a computer and internet access
  • Does note speak and read English
  • Previously participated in CONFIDENCE program

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Western Reserve University

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving

The purpose of this study is to determine how feasible it is to deliver an online course to reduce out-of-pocket costs of caregiving and reduce financial stress among Latino family caregivers to a family member living with dementia. The investigators hope that that the results of this study will help to reduce high these out-of-pocket costs and improve financial wellbeing for Latino family caregivers.

Caregivers will be asked to to participate in 3 online surveys, in addition to participating in 5, 1.5 hour group-based Zoom learning sessions.

Being tested
Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving
Keywords
Out-of-pocket costs, Behavioral intervention, Hispanic, Latino, Self-Efficacy
Medical subject headings
Caregiver Burden, Financial Stress, Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia CaregivingBehavioural

    Multicomponent psychoeducational intervention focused on financial wellbeing

Study groups in NCT05292248
Study groupRoleWhat they receive
CONFIDENCE Education InterventionExperimentalParticipants will attend the 5-week CONFIDENCEProgram. This program will include attending 5 group-based sessions delivered by videoconference. Each session will last approximately 1.5 hours each and will cover topics such as how to budget, accessing community resources to displace the out-of-pocket costs of caregiving, asking for help, balancing employment and caregiving, and more.
Receives: Behavioral: Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monthly Out-of-pocket Caregiving Costs

    Monthly out-of-pocket costs of caregiving is based on the tool used by the AARP Public Policy Institute in their 2016 report on the out-of-pocket costs of caregiving. This measure combines caregiver recall of care costs in the previous month, collected at baseline, with 5 days of daily spending diaries. Daily surveys will be sent using an email with a survey link, and a text message reminder. Monthly costs include less-frequent, high-cost expenditures (e.g., mortgage payment), while daily costs include lower-cost items caregivers may pay for more frequently (e.g., groceries). Daily self-reports of spending will be averaged and multiplied by 6 to approximate the number of days in a month, and added to estimated monthly costs.

    Positive scores indicate increased out-of-pocket costs. The researchers advise against relying on this outcome. In this pilot study, we found that this measure has qualitatively different meanings for adult child and spousal caregivers.

    Measured: Change in median costs from from baseline to 8 weeks post-intervention

Secondary outcomes (3)

  1. Psychological Financial Strain

    The measure for psychological financial strain is from multiple scales. Items 1 to 14 ask about financial anxiety. Lastly, the investigators included the 1-item question that asks about financial worry ("I worry constantly about money". Participants are asked to indicate the extent to which each statement is true (Very true [3], Somewhat true[2], Somewhat untrue[1], and Complete untrue[0]). Scores are summed such that scores range from 0 to 45, where higher scores indicate higher levels of financial strain.

    Measured: Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

  2. Caregiver Self-efficacy

    Self-efficacy is measured using the Caregiver Self-Efficacy Scale. This 8-item scale asks about multiples domains of self-efficacy (e.g., managing behavioral symptoms, accessing respite, and controlling upsetting thoughts). It demonstrates high reliability (alpha=0.89) and good test-retest reliability (0.73). Participants rate the extent to which they are "Not confident at all" (1) to "Totally confident" (10). Scores range from 8 (lowest level of self-efficacy) to 80 (highest level of self-efficacy). The outcome measure will use the average change score from baseline scores. Positive scores indicate an increase in self-efficacy.

    Measured: Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

  3. Caregiver Resourcefulness

    Resourcefulness is measured using the 28-item Caregiver Resourcefulness Scale (alpha=0.85). This scale has two factors: one focused on help-seeking and another on self-help. Caregivers are asked the frequency at which they use different strategies to manage challenges, and may respond: Not at all like me (0), Pretty much not like me (1), A little bit not like me (2), A little bit like me (3), Pretty much like much like me (4), or Very much like me (5). Items are added together to create a total score. Scores range from 0 to 140, where higher scores indicate higher levels of resourcefulness. The outcome measure will use the average change score from baseline scores

    Measured: Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2022
  2. Study start1 May 2022
  3. Primary completion15 Dec 2023
  4. Study completion1 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292248
Sponsor's protocol ID
20210794HU
Acronym
CONFIDENCE
Status last verified
Aug 2024
First submitted
14 Mar 2022
Last updated
23 Aug 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data will be made available to qualified investigators upon request to the PI.

Publications

  • Rainville C, Skufca L, Mehegan L. Family Caregiving and Out-of-Pocket Costs: 2016 Report: AARP; 2016. https://www.khi.org/assets/uploads/news/14680/family-caregiving-cost-survey-res-ltc.pdf

  • Norvilitis JM, Szablicki PB, Wilson SD. Factors Influencing Levels of Credit-Card Debt in College Students. J of Applied Social Psychology 2003;33(5):935-47.

  • Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K. Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist. 2022 Mar 28;62(3):e140-e149. doi: 10.1093/geront/gnaa174.

    PubMed 33146727

  • Shim S, Barber BL, Card NA, Xiao JJ, Serido J. Financial socialization of first-year college students: the roles of parents, work, and education. J Youth Adolesc. 2010 Dec;39(12):1457-70. doi: 10.1007/s10964-009-9432-x. Epub 2009 Jul 4.

    PubMed 20938727

  • Shapiro GK, Burchell BJ. Measuring financial anxiety. Journal of Neuroscience, Psychology, and Economics. 2012;5(2):92-103.

  • Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006 Spring-Summer;14(1):57-68. doi: 10.1891/jnum.14.1.57.

    PubMed 16764178

  • Meyer K, Mage SM, Gonzalez A, Zauszniewski JA, Rhodes S, Perales-Puchalt J, Wilber K, Song L, Puga F, Benton D. Lessons from a Pilot Study of a Culturally Tailored Financial Well-Being Intervention Among Latino Family Caregivers. J Appl Gerontol. 2025 Jun;44(6):938-948. doi: 10.1177/07334648241293524. Epub 2024 Oct 17.

    PubMed 39420566

Questions about this trial

What is this clinical trial studying?

A study testing Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving in people with Caregiver Burden and Financial Stress, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monthly Out-of-pocket Caregiving Costs (time frame: Change in median costs from from baseline to 8 weeks post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05292248, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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